{"id":597309,"date":"2024-06-07T13:21:51","date_gmt":"2024-06-07T05:21:51","guid":{"rendered":""},"modified":"2024-06-07T13:21:54","modified_gmt":"2024-06-07T05:21:54","slug":"gmp%e6%96%87%e6%a1%a3%e7%ae%a1%e7%90%86%e8%bd%af%e4%bb%b6%e6%9c%89%e5%93%aa%e4%ba%9b","status":"publish","type":"post","link":"https:\/\/docs.pingcode.com\/ask\/597309.html","title":{"rendered":"gmp\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u6709\u54ea\u4e9b"},"content":{"rendered":"

\"gmp\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u6709\u54ea\u4e9b\"<\/p>\n

GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u6709\u54ea\u4e9b\uff1f<\/strong> MasterControl\u3001Veeva Vault\u3001Qualio\u3001Qumas DocCompliance\u3001Limsophy<\/strong>\uff0c\u5176\u4e2dMasterControl<\/strong>\u662f\u4e00\u6b3e\u975e\u5e38\u5f3a\u5927\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\uff0c\u5176\u529f\u80fd\u5305\u62ec\u6587\u6863\u63a7\u5236\u3001\u57f9\u8bad\u7ba1\u7406\u3001\u5ba1\u6838\u8ddf\u8e2a\u548c\u53d8\u66f4\u63a7\u5236\u7b49\uff0c\u80fd\u591f\u5e2e\u52a9\u5236\u836f\u516c\u53f8\u548c\u751f\u7269\u6280\u672f\u516c\u53f8\u786e\u4fdd\u5176\u6587\u6863\u7b26\u5408GMP\uff08Good Manufacturing Practice\uff09\u8981\u6c42\u3002MasterControl\u901a\u8fc7\u81ea\u52a8\u5316\u7684\u5de5\u4f5c\u6d41\u7a0b\u548c\u7535\u5b50\u7b7e\u540d\u529f\u80fd\uff0c\u63d0\u9ad8\u4e86\u6587\u6863\u7ba1\u7406\u7684\u6548\u7387\u548c\u5408\u89c4\u6027\uff0c\u4ece\u800c\u5927\u5927\u51cf\u5c11\u4e86\u4f01\u4e1a\u5728\u5ba1\u8ba1\u548c\u5408\u89c4\u68c0\u67e5\u4e2d\u7684\u98ce\u9669\u3002<\/p>\n<\/p>\n

\n

\u4e00\u3001GMP\u6587\u6863\u7ba1\u7406\u7684\u91cd\u8981\u6027<\/h3>\n<\/p>\n

GMP\uff08Good Manufacturing Practice\uff09\u662f\u6307\u826f\u597d\u7684\u751f\u4ea7\u89c4\u8303\uff0c\u4e3b\u8981\u7528\u4e8e\u786e\u4fdd\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u6027\u3002\u5728\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u3001\u98df\u54c1\u7b49\u884c\u4e1a\uff0cGMP\u6587\u6863\u7ba1\u7406\u81f3\u5173\u91cd\u8981\u3002\u901a\u8fc7\u6709\u6548\u7684\u6587\u6863\u7ba1\u7406\uff0c\u4f01\u4e1a\u53ef\u4ee5\u786e\u4fdd\u5176\u751f\u4ea7\u6d41\u7a0b\u3001\u64cd\u4f5c\u89c4\u7a0b\u3001\u8d28\u91cf\u63a7\u5236\u7b49\u65b9\u9762\u90fd\u7b26\u5408GMP\u8981\u6c42\uff0c\u4ece\u800c\u964d\u4f4e\u4ea7\u54c1\u8d28\u91cf\u98ce\u9669\u548c\u5408\u89c4\u98ce\u9669\u3002<\/p>\n<\/p>\n

1. \u5408\u89c4\u6027\u4fdd\u969c<\/h4>\n<\/p>\n

GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u53ef\u4ee5\u786e\u4fdd\u6240\u6709\u751f\u4ea7\u6d41\u7a0b\u548c\u64cd\u4f5c\u90fd\u7b26\u5408\u76d1\u7ba1\u673a\u6784\u7684\u8981\u6c42\uff0c\u5982FDA\u3001EMA\u7b49\u3002\u8fd9\u4e9b\u8f6f\u4ef6\u901a\u8fc7\u81ea\u52a8\u5316\u7684\u5de5\u4f5c\u6d41\u7a0b\u548c\u7535\u5b50\u7b7e\u540d\u529f\u80fd\uff0c\u786e\u4fdd\u6240\u6709\u6587\u6863\u7684\u751f\u6210\u3001\u4fee\u6539\u548c\u5ba1\u6838\u90fd\u7b26\u5408\u89c4\u5b9a\uff0c\u907f\u514d\u4eba\u4e3a\u9519\u8bef\u548c\u8fdd\u89c4\u64cd\u4f5c\u3002<\/p>\n<\/p>\n

2. \u63d0\u9ad8\u6548\u7387<\/h4>\n<\/p>\n

\u4f20\u7edf\u7684\u7eb8\u8d28\u6587\u6863\u7ba1\u7406\u4e0d\u4ec5\u7e41\u7410\uff0c\u800c\u4e14\u5bb9\u6613\u51fa\u9519\u3002GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u901a\u8fc7\u6570\u5b57\u5316\u548c\u81ea\u52a8\u5316\u7684\u65b9\u5f0f\uff0c\u5927\u5927\u63d0\u9ad8\u4e86\u6587\u6863\u7ba1\u7406\u7684\u6548\u7387\u3002\u4f8b\u5982\uff0c\u8f6f\u4ef6\u53ef\u4ee5\u81ea\u52a8\u63d0\u9192\u6587\u6863\u7684\u5ba1\u6838\u548c\u66f4\u65b0\uff0c\u907f\u514d\u9057\u6f0f\u548c\u5ef6\u8bef\u3002\u540c\u65f6\uff0c\u7535\u5b50\u7b7e\u540d\u529f\u80fd\u4e5f\u7b80\u5316\u4e86\u5ba1\u6279\u6d41\u7a0b\uff0c\u51cf\u5c11\u4e86\u65f6\u95f4\u548c\u4eba\u529b\u6210\u672c\u3002<\/p>\n<\/p>\n

\u4e8c\u3001MASTERCONTROL<\/h3>\n<\/p>\n

MasterControl\u662f\u4e00\u6b3e\u975e\u5e38\u5f3a\u5927\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\uff0c\u5e7f\u6cdb\u5e94\u7528\u4e8e\u5236\u836f\u548c\u751f\u7269\u6280\u672f\u884c\u4e1a\u3002\u5b83\u7684\u4e3b\u8981\u529f\u80fd\u5305\u62ec\u6587\u6863\u63a7\u5236\u3001\u57f9\u8bad\u7ba1\u7406\u3001\u5ba1\u6838\u8ddf\u8e2a\u548c\u53d8\u66f4\u63a7\u5236\u7b49\u3002<\/p>\n<\/p>\n

1. \u6587\u6863\u63a7\u5236<\/h4>\n<\/p>\n

MasterControl\u7684\u6587\u6863\u63a7\u5236\u529f\u80fd\u975e\u5e38\u5f3a\u5927\u3002\u901a\u8fc7\u8fd9\u9879\u529f\u80fd\uff0c\u7528\u6237\u53ef\u4ee5\u8f7b\u677e\u521b\u5efa\u3001\u4fee\u6539\u3001\u5ba1\u6838\u548c\u6279\u51c6\u5404\u79cdGMP\u6587\u6863\u3002\u8f6f\u4ef6\u63d0\u4f9b\u4e86\u7248\u672c\u63a7\u5236\u548c\u53d8\u66f4\u8bb0\u5f55\uff0c\u786e\u4fdd\u6bcf\u4e2a\u6587\u6863\u7684\u5386\u53f2\u8bb0\u5f55\u90fd\u53ef\u4ee5\u8ffd\u6eaf\u3002\u6b64\u5916\uff0c\u81ea\u52a8\u5316\u7684\u5de5\u4f5c\u6d41\u7a0b\u548c\u7535\u5b50\u7b7e\u540d\u529f\u80fd\u786e\u4fdd\u4e86\u6587\u6863\u7684\u5408\u89c4\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n

2. \u57f9\u8bad\u7ba1\u7406<\/h4>\n<\/p>\n

\u5728GMP\u73af\u5883\u4e2d\uff0c\u5458\u5de5\u7684\u57f9\u8bad\u548c\u8d44\u683c\u8ba4\u8bc1\u81f3\u5173\u91cd\u8981\u3002MasterControl\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u57f9\u8bad\u7ba1\u7406\u529f\u80fd\uff0c\u53ef\u4ee5\u81ea\u52a8\u8ddf\u8e2a\u5458\u5de5\u7684\u57f9\u8bad\u8fdb\u5ea6\u548c\u8d44\u683c\u8ba4\u8bc1\u72b6\u6001\u3002\u8f6f\u4ef6\u8fd8\u53ef\u4ee5\u751f\u6210\u57f9\u8bad\u62a5\u544a\uff0c\u5e2e\u52a9\u4f01\u4e1a\u8fdb\u884c\u5185\u90e8\u5ba1\u6838\u548c\u5916\u90e8\u5ba1\u8ba1\u3002<\/p>\n<\/p>\n

\u4e09\u3001VEEVA VAULT<\/h3>\n<\/p>\n

Veeva Vault\u662f\u4e00\u6b3e\u4e13\u4e3a\u751f\u547d\u79d1\u5b66\u884c\u4e1a\u8bbe\u8ba1\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u3002\u5b83\u901a\u8fc7\u4e91\u7aef\u5e73\u53f0\u63d0\u4f9b\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u89e3\u51b3\u65b9\u6848\uff0c\u5305\u62ec\u6587\u6863\u63a7\u5236\u3001\u8d28\u91cf\u7ba1\u7406\u3001\u4e34\u5e8a\u8bd5\u9a8c\u7ba1\u7406\u7b49\u3002<\/p>\n<\/p>\n

1. \u4e91\u7aef\u5e73\u53f0<\/h4>\n<\/p>\n

Veeva Vault\u57fa\u4e8e\u4e91\u7aef\u5e73\u53f0\uff0c\u7528\u6237\u53ef\u4ee5\u968f\u65f6\u968f\u5730\u8bbf\u95ee\u548c\u7ba1\u7406\u6587\u6863\u3002\u4e91\u7aef\u5e73\u53f0\u4e0d\u4ec5\u63d0\u9ad8\u4e86\u6587\u6863\u7ba1\u7406\u7684\u4fbf\u6377\u6027\uff0c\u8fd8\u786e\u4fdd\u4e86\u6587\u6863\u7684\u5b89\u5168\u6027\u548c\u5408\u89c4\u6027\u3002\u901a\u8fc7\u591a\u5c42\u6b21\u7684\u5b89\u5168\u63aa\u65bd\u548c\u6743\u9650\u63a7\u5236\uff0cVeeva Vault\u786e\u4fdd\u4e86\u6587\u6863\u7684\u673a\u5bc6\u6027\u548c\u5b8c\u6574\u6027\u3002<\/p>\n<\/p>\n

2. \u8d28\u91cf\u7ba1\u7406<\/h4>\n<\/p>\n

\u8d28\u91cf\u7ba1\u7406\u662fGMP\u6587\u6863\u7ba1\u7406\u7684\u91cd\u8981\u7ec4\u6210\u90e8\u5206\u3002Veeva Vault\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u8d28\u91cf\u7ba1\u7406\u529f\u80fd\uff0c\u5305\u62ec\u4e0d\u5408\u683c\u62a5\u544a\u3001CAPA\uff08\u7ea0\u6b63\u548c\u9884\u9632\u63aa\u65bd\uff09\u3001\u5ba1\u8ba1\u7ba1\u7406\u7b49\u3002\u901a\u8fc7\u8fd9\u4e9b\u529f\u80fd\uff0c\u4f01\u4e1a\u53ef\u4ee5\u5168\u9762\u76d1\u63a7\u548c\u6539\u8fdb\u5176\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff0c\u786e\u4fdd\u4ea7\u54c1\u7684\u8d28\u91cf\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n

\u56db\u3001QUALIO<\/h3>\n<\/p>\n

Qualio\u662f\u4e00\u6b3e\u4e13\u4e3a\u5c0f\u578b\u548c\u4e2d\u578b\u4f01\u4e1a\u8bbe\u8ba1\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u3002\u5b83\u63d0\u4f9b\u4e86\u7b80\u6d01\u6613\u7528\u7684\u754c\u9762\u548c\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd\uff0c\u5e2e\u52a9\u4f01\u4e1a\u786e\u4fdd\u5176\u6587\u6863\u7b26\u5408GMP\u8981\u6c42\u3002<\/p>\n<\/p>\n

1. \u7b80\u6d01\u6613\u7528<\/h4>\n<\/p>\n

Qualio\u7684\u754c\u9762\u8bbe\u8ba1\u975e\u5e38\u7b80\u6d01\uff0c\u7528\u6237\u53ef\u4ee5\u8f7b\u677e\u4e0a\u624b\u3002\u8f6f\u4ef6\u63d0\u4f9b\u4e86\u76f4\u89c2\u7684\u5de5\u4f5c\u6d41\u7a0b\u548c\u81ea\u52a8\u5316\u63d0\u9192\u529f\u80fd\uff0c\u5e2e\u52a9\u7528\u6237\u9ad8\u6548\u7ba1\u7406\u6587\u6863\u3002\u5373\u4f7f\u6ca1\u6709\u4e30\u5bcc\u7684IT\u7ecf\u9a8c\uff0c\u7528\u6237\u4e5f\u53ef\u4ee5\u8f7b\u677e\u4f7f\u7528Qualio\u8fdb\u884c\u6587\u6863\u7ba1\u7406\u3002<\/p>\n<\/p>\n

2. \u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd<\/h4>\n<\/p>\n

Qualio\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd\uff0c\u5305\u62ec\u6587\u6863\u521b\u5efa\u3001\u4fee\u6539\u3001\u5ba1\u6838\u548c\u6279\u51c6\u3002\u8f6f\u4ef6\u8fd8\u63d0\u4f9b\u4e86\u7248\u672c\u63a7\u5236\u548c\u53d8\u66f4\u8bb0\u5f55\uff0c\u786e\u4fdd\u6bcf\u4e2a\u6587\u6863\u7684\u5386\u53f2\u8bb0\u5f55\u90fd\u53ef\u4ee5\u8ffd\u6eaf\u3002\u6b64\u5916\uff0cQualio\u8fd8\u652f\u6301\u7535\u5b50\u7b7e\u540d\u529f\u80fd\uff0c\u786e\u4fdd\u6587\u6863\u7684\u5408\u89c4\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n

\u4e94\u3001QUMAS DOCCOMPLIANCE<\/h3>\n<\/p>\n

Qumas DocCompliance\u662f\u4e00\u6b3e\u4e13\u4e3a\u751f\u547d\u79d1\u5b66\u884c\u4e1a\u8bbe\u8ba1\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u3002\u5b83\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u89e3\u51b3\u65b9\u6848\uff0c\u5e2e\u52a9\u4f01\u4e1a\u786e\u4fdd\u5176\u6587\u6863\u7b26\u5408GMP\u8981\u6c42\u3002<\/p>\n<\/p>\n

1. \u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd<\/h4>\n<\/p>\n

Qumas DocCompliance\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd\uff0c\u5305\u62ec\u6587\u6863\u63a7\u5236\u3001\u57f9\u8bad\u7ba1\u7406\u3001\u5ba1\u6838\u8ddf\u8e2a\u548c\u53d8\u66f4\u63a7\u5236\u3002\u901a\u8fc7\u8fd9\u4e9b\u529f\u80fd\uff0c\u4f01\u4e1a\u53ef\u4ee5\u9ad8\u6548\u7ba1\u7406\u5176GMP\u6587\u6863\uff0c\u786e\u4fdd\u5176\u5408\u89c4\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n

2. \u81ea\u52a8\u5316\u5de5\u4f5c\u6d41\u7a0b<\/h4>\n<\/p>\n

Qumas DocCompliance\u7684\u81ea\u52a8\u5316\u5de5\u4f5c\u6d41\u7a0b\u529f\u80fd\u975e\u5e38\u5f3a\u5927\u3002\u7528\u6237\u53ef\u4ee5\u6839\u636e\u9700\u8981\u81ea\u5b9a\u4e49\u5de5\u4f5c\u6d41\u7a0b\uff0c\u81ea\u52a8\u5316\u6587\u6863\u7684\u751f\u6210\u3001\u4fee\u6539\u3001\u5ba1\u6838\u548c\u6279\u51c6\u8fc7\u7a0b\u3002\u8f6f\u4ef6\u8fd8\u63d0\u4f9b\u4e86\u81ea\u52a8\u63d0\u9192\u529f\u80fd\uff0c\u786e\u4fdd\u6587\u6863\u7684\u53ca\u65f6\u66f4\u65b0\u548c\u5ba1\u6838\u3002<\/p>\n<\/p>\n

\u516d\u3001LIMSOPHY<\/h3>\n<\/p>\n

Limsophy\u662f\u4e00\u6b3e\u4e13\u4e3a\u5b9e\u9a8c\u5ba4\u548c\u5236\u836f\u884c\u4e1a\u8bbe\u8ba1\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u3002\u5b83\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u548c\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u529f\u80fd\uff0c\u5e2e\u52a9\u4f01\u4e1a\u786e\u4fdd\u5176\u6587\u6863\u7b26\u5408GMP\u8981\u6c42\u3002<\/p>\n<\/p>\n

1. \u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406<\/h4>\n<\/p>\n

Limsophy\u4e0d\u4ec5\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd\uff0c\u8fd8\u63d0\u4f9b\u4e86\u5b9e\u9a8c\u5ba4\u4fe1\u606f\u7ba1\u7406\u529f\u80fd\u3002\u7528\u6237\u53ef\u4ee5\u901a\u8fc7\u8f6f\u4ef6\u7ba1\u7406\u5b9e\u9a8c\u5ba4\u7684\u5404\u79cd\u6570\u636e\u548c\u4fe1\u606f\uff0c\u5982\u5b9e\u9a8c\u7ed3\u679c\u3001\u8bbe\u5907\u72b6\u6001\u3001\u8bd5\u5242\u5e93\u5b58\u7b49\u3002\u901a\u8fc7\u8fd9\u4e9b\u529f\u80fd\uff0c\u4f01\u4e1a\u53ef\u4ee5\u5168\u9762\u76d1\u63a7\u548c\u7ba1\u7406\u5176\u5b9e\u9a8c\u5ba4\u64cd\u4f5c\uff0c\u786e\u4fdd\u5176\u5408\u89c4\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n

2. \u6587\u6863\u7ba1\u7406<\/h4>\n<\/p>\n

Limsophy\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd\u975e\u5e38\u5f3a\u5927\u3002\u7528\u6237\u53ef\u4ee5\u8f7b\u677e\u521b\u5efa\u3001\u4fee\u6539\u3001\u5ba1\u6838\u548c\u6279\u51c6\u5404\u79cdGMP\u6587\u6863\u3002\u8f6f\u4ef6\u63d0\u4f9b\u4e86\u7248\u672c\u63a7\u5236\u548c\u53d8\u66f4\u8bb0\u5f55\uff0c\u786e\u4fdd\u6bcf\u4e2a\u6587\u6863\u7684\u5386\u53f2\u8bb0\u5f55\u90fd\u53ef\u4ee5\u8ffd\u6eaf\u3002\u6b64\u5916\uff0c\u81ea\u52a8\u5316\u7684\u5de5\u4f5c\u6d41\u7a0b\u548c\u7535\u5b50\u7b7e\u540d\u529f\u80fd\u786e\u4fdd\u4e86\u6587\u6863\u7684\u5408\u89c4\u6027\u548c\u5b89\u5168\u6027\u3002<\/p>\n<\/p>\n

\u4e03\u3001\u603b\u7ed3<\/h3>\n<\/p>\n

\u5728\u5236\u836f\u3001\u751f\u7269\u6280\u672f\u548c\u5176\u4ed6\u53d7GMP\u76d1\u7ba1\u7684\u884c\u4e1a\u4e2d\uff0c\u6587\u6863\u7ba1\u7406\u662f\u786e\u4fdd\u4ea7\u54c1\u8d28\u91cf\u548c\u5408\u89c4\u6027\u7684\u5173\u952e\u73af\u8282\u3002\u901a\u8fc7\u4f7f\u7528\u4e13\u4e1a\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\uff0c\u5982MasterControl\u3001Veeva Vault\u3001Qualio\u3001Qumas DocCompliance\u548cLimsophy\uff0c\u4f01\u4e1a\u53ef\u4ee5\u9ad8\u6548\u7ba1\u7406\u5176\u6587\u6863\uff0c\u786e\u4fdd\u5176\u751f\u4ea7\u6d41\u7a0b\u548c\u64cd\u4f5c\u89c4\u7a0b\u7b26\u5408GMP\u8981\u6c42\u3002\u8fd9\u4e9b\u8f6f\u4ef6\u63d0\u4f9b\u4e86\u5168\u9762\u7684\u6587\u6863\u7ba1\u7406\u529f\u80fd\u548c\u81ea\u52a8\u5316\u7684\u5de5\u4f5c\u6d41\u7a0b\uff0c\u5927\u5927\u63d0\u9ad8\u4e86\u6587\u6863\u7ba1\u7406\u7684\u6548\u7387\u548c\u5408\u89c4\u6027\uff0c\u5e2e\u52a9\u4f01\u4e1a\u964d\u4f4e\u4e86\u4ea7\u54c1\u8d28\u91cf\u98ce\u9669\u548c\u5408\u89c4\u98ce\u9669\u3002<\/p>\n<\/p>\n

\u76f8\u5173\u95ee\u7b54FAQs\uff1a<\/strong><\/h2>\n

1. GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u6709\u54ea\u4e9b\u529f\u80fd\uff1f<\/strong><\/p>\n

GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u901a\u5e38\u5177\u6709\u4ee5\u4e0b\u529f\u80fd\uff1a<\/p>\n

    \n
  • \u6587\u6863\u5206\u7c7b\u548c\u6807\u7b7e<\/strong>\uff1a\u53ef\u4ee5\u6839\u636e\u4e0d\u540c\u7684\u5206\u7c7b\u548c\u6807\u7b7e\u5bf9\u6587\u6863\u8fdb\u884c\u7ec4\u7ec7\u548c\u5f52\u6863\uff0c\u65b9\u4fbf\u67e5\u627e\u548c\u7ba1\u7406\u3002<\/li>\n
  • \u7248\u672c\u63a7\u5236<\/strong>\uff1a\u80fd\u591f\u5bf9\u6587\u6863\u8fdb\u884c\u7248\u672c\u7ba1\u7406\uff0c\u8bb0\u5f55\u6bcf\u6b21\u7684\u4fee\u6539\u548c\u66f4\u65b0\uff0c\u5e76\u53ef\u4ee5\u968f\u65f6\u56de\u6eaf\u5230\u5386\u53f2\u7248\u672c\u3002<\/li>\n
  • \u6743\u9650\u7ba1\u7406<\/strong>\uff1a\u53ef\u4ee5\u8bbe\u7f6e\u4e0d\u540c\u7528\u6237\u6216\u7528\u6237\u7ec4\u7684\u6743\u9650\uff0c\u4fdd\u62a4\u6587\u6863\u7684\u5b89\u5168\u6027\u548c\u673a\u5bc6\u6027\u3002<\/li>\n
  • \u5728\u7ebf\u534f\u4f5c<\/strong>\uff1a\u652f\u6301\u591a\u4eba\u5728\u7ebf\u534f\u4f5c\u7f16\u8f91\u548c\u8bc4\u8bba\uff0c\u65b9\u4fbf\u56e2\u961f\u6210\u5458\u4e4b\u95f4\u7684\u6c9f\u901a\u548c\u5408\u4f5c\u3002<\/li>\n
  • \u5ba1\u6279\u6d41\u7a0b<\/strong>\uff1a\u53ef\u4ee5\u8bbe\u5b9a\u6587\u6863\u7684\u5ba1\u6279\u6d41\u7a0b\uff0c\u786e\u4fdd\u6587\u6863\u7684\u5408\u89c4\u6027\u548c\u51c6\u786e\u6027\u3002<\/li>\n
  • \u5168\u6587\u641c\u7d22<\/strong>\uff1a\u80fd\u591f\u901a\u8fc7\u5173\u952e\u8bcd\u5bf9\u6587\u6863\u8fdb\u884c\u5168\u6587\u641c\u7d22\uff0c\u5feb\u901f\u5b9a\u4f4d\u9700\u8981\u7684\u4fe1\u606f\u3002<\/li>\n
  • \u5907\u4efd\u548c\u6062\u590d<\/strong>\uff1a\u63d0\u4f9b\u6587\u6863\u7684\u5907\u4efd\u548c\u6062\u590d\u529f\u80fd\uff0c\u9632\u6b62\u6570\u636e\u4e22\u5931\u6216\u635f\u574f\u3002<\/li>\n<\/ul>\n

    2. GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u7684\u4f18\u52bf\u662f\u4ec0\u4e48\uff1f<\/strong><\/p>\n

    GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u76f8\u6bd4\u4f20\u7edf\u7684\u6587\u4ef6\u7ba1\u7406\u65b9\u5f0f\u5177\u6709\u4e00\u4e9b\u4f18\u52bf\uff1a<\/p>\n

      \n
    • \u9ad8\u6548\u7ba1\u7406<\/strong>\uff1a\u901a\u8fc7\u81ea\u52a8\u5316\u7684\u6587\u6863\u5206\u7c7b\u3001\u7248\u672c\u63a7\u5236\u548c\u6743\u9650\u7ba1\u7406\uff0c\u5927\u5927\u63d0\u9ad8\u4e86\u6587\u6863\u7ba1\u7406\u7684\u6548\u7387\uff0c\u8282\u7701\u4e86\u65f6\u95f4\u548c\u4eba\u529b\u6210\u672c\u3002<\/li>\n
    • \u5b89\u5168\u6027<\/strong>\uff1a\u901a\u8fc7\u6743\u9650\u7ba1\u7406\u548c\u5ba1\u6279\u6d41\u7a0b\uff0c\u786e\u4fdd\u6587\u6863\u7684\u5b89\u5168\u6027\u548c\u673a\u5bc6\u6027\uff0c\u9632\u6b62\u672a\u7ecf\u6388\u6743\u7684\u4eba\u5458\u67e5\u770b\u6216\u4fee\u6539\u6587\u6863\u3002<\/li>\n
    • \u534f\u4f5c\u6027<\/strong>\uff1a\u652f\u6301\u591a\u4eba\u5728\u7ebf\u534f\u4f5c\u7f16\u8f91\u548c\u8bc4\u8bba\uff0c\u65b9\u4fbf\u56e2\u961f\u6210\u5458\u4e4b\u95f4\u7684\u6c9f\u901a\u548c\u5408\u4f5c\uff0c\u63d0\u9ad8\u4e86\u56e2\u961f\u7684\u534f\u4f5c\u6548\u7387\u3002<\/li>\n
    • \u6613\u4e8e\u67e5\u627e<\/strong>\uff1a\u901a\u8fc7\u6587\u6863\u5206\u7c7b\u3001\u6807\u7b7e\u548c\u5168\u6587\u641c\u7d22\uff0c\u53ef\u4ee5\u5feb\u901f\u5b9a\u4f4d\u9700\u8981\u7684\u6587\u6863\uff0c\u65b9\u4fbf\u67e5\u627e\u548c\u7ba1\u7406\u3002<\/li>\n
    • \u53ef\u8ffd\u6eaf\u6027<\/strong>\uff1a\u901a\u8fc7\u7248\u672c\u63a7\u5236\u529f\u80fd\uff0c\u8bb0\u5f55\u6bcf\u6b21\u7684\u4fee\u6539\u548c\u66f4\u65b0\uff0c\u53ef\u4ee5\u968f\u65f6\u56de\u6eaf\u5230\u5386\u53f2\u7248\u672c\uff0c\u8ffd\u6eaf\u6587\u6863\u7684\u53d8\u66f4\u5386\u53f2\u3002<\/li>\n<\/ul>\n

      3. \u5982\u4f55\u9009\u62e9\u9002\u5408\u81ea\u5df1\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\uff1f<\/strong><\/p>\n

      \u9009\u62e9\u9002\u5408\u81ea\u5df1\u7684GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u65f6\uff0c\u53ef\u4ee5\u8003\u8651\u4ee5\u4e0b\u51e0\u4e2a\u56e0\u7d20\uff1a<\/p>\n

        \n
      • \u529f\u80fd\u9700\u6c42<\/strong>\uff1a\u6839\u636e\u81ea\u5df1\u7684\u5177\u4f53\u9700\u6c42\uff0c\u9009\u62e9\u529f\u80fd\u9f50\u5168\u4e14\u7b26\u5408\u81ea\u5df1\u8981\u6c42\u7684\u8f6f\u4ef6\uff0c\u4f8b\u5982\u662f\u5426\u9700\u8981\u7248\u672c\u63a7\u5236\u3001\u6743\u9650\u7ba1\u7406\u3001\u5728\u7ebf\u534f\u4f5c\u7b49\u529f\u80fd\u3002<\/li>\n
      • \u7528\u6237\u53cb\u597d\u6027<\/strong>\uff1a\u9009\u62e9\u754c\u9762\u7b80\u6d01\u3001\u64cd\u4f5c\u7b80\u5355\u7684\u8f6f\u4ef6\uff0c\u65b9\u4fbf\u7528\u6237\u4e0a\u624b\u548c\u4f7f\u7528\uff0c\u51cf\u5c11\u57f9\u8bad\u6210\u672c\u3002<\/li>\n
      • \u5b89\u5168\u6027<\/strong>\uff1a\u9009\u62e9\u5177\u5907\u4e25\u683c\u7684\u6743\u9650\u7ba1\u7406\u548c\u6570\u636e\u52a0\u5bc6\u529f\u80fd\u7684\u8f6f\u4ef6\uff0c\u786e\u4fdd\u6587\u6863\u7684\u5b89\u5168\u6027\u548c\u673a\u5bc6\u6027\u3002<\/li>\n
      • \u53ef\u6269\u5c55\u6027<\/strong>\uff1a\u9009\u62e9\u5177\u5907\u826f\u597d\u7684\u6269\u5c55\u6027\u548c\u5b9a\u5236\u6027\u7684\u8f6f\u4ef6\uff0c\u53ef\u4ee5\u6839\u636e\u81ea\u5df1\u7684\u4e1a\u52a1\u9700\u6c42\u8fdb\u884c\u5b9a\u5236\u548c\u6269\u5c55\u3002<\/li>\n
      • \u7528\u6237\u8bc4\u4ef7<\/strong>\uff1a\u53ef\u4ee5\u53c2\u8003\u5176\u4ed6\u7528\u6237\u7684\u8bc4\u4ef7\u548c\u53cd\u9988\uff0c\u4e86\u89e3\u8f6f\u4ef6\u7684\u4f18\u7f3a\u70b9\uff0c\u5e2e\u52a9\u81ea\u5df1\u505a\u51fa\u51b3\u7b56\u3002<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"GMP\u6587\u6863\u7ba1\u7406\u8f6f\u4ef6\u6709\u54ea\u4e9b\uff1f MasterControl\u3001Veeva Vault\u3001Qualio\u3001Qumas Do […]","protected":false},"author":3,"featured_media":597314,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[37],"tags":[],"acf":[],"_links":{"self":[{"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/posts\/597309"}],"collection":[{"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/comments?post=597309"}],"version-history":[{"count":"1","href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/posts\/597309\/revisions"}],"predecessor-version":[{"id":597315,"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/posts\/597309\/revisions\/597315"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/media\/597314"}],"wp:attachment":[{"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/media?parent=597309"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/categories?post=597309"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/docs.pingcode.com\/wp-json\/wp\/v2\/tags?post=597309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}